FDA Warning for Samsca (tolvaptan) Liver Injury

January 25, 2013 — According to a new Drug Safety Communication published by the U.S. Food and Drug Administration, the medication Samsca (tolvaptan) has been linked to irreversible, life-threatening liver injury. Samsca is prescribed to patients who have hyponatremia, or too much water in their blood and not enough sodium. The FDA is recommending that doctors check symptomatic Samsca patients for liver damage.

The manufacturer of Samsca, Otsuka America Pharmaceutical, sent a letter to physicians on January 22 to warn them about the potential risks:

“An external panel of liver experts assessed these three cases as being either probably or highly likely to be caused by tolvaptan. These findings indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury.”

Researchers identified the risk of liver injury during a 3-year clinical trial that involved the highest dose of Samsca — patients were given 90-mg in the morning, and 30-mg in the afternoon. This maximum dose of 120-mg per day is double the 60-mg dose that is approved for hyponatremia. However, even the lower dose could increase the risk of liver damage.

The researchers gave maximum-dose Samsca to 1400 patients, and three developed “significant” levels of liver enzymes in their blood, indicating liver damage. All three were taken off Samsca and improved.

The study also found that patients who were given Samsca were significantly more likely to have elevated levels of ALT, which is an enzyme the liver releases when it is damaged. Levels of ALT were 3-times higher than “normal” in 42 of 958 Samsca patients, compared to 5 of 484 patients on a placebo.

Researchers were concerned about irreversible liver damage in Samsca patients, especially those with underlying liver problems. These serious injuries could potentially lead to liver failure and death.

The FDA recommends that physicians should evaluate patients with the following symptoms of liver injury:

Fatigue

Anorexia

Right upper abdominal discomfort

Dark urine

Jaundice (yellowing of the skin and/or eyes)

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